Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib. - SAFFRO

Hibi Kazushige0 sites324 target enrollmentOctober 27, 2022

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hibi Kazushige

•Provision of signed and dated written ICF prior to any mandatory and non\-mandatory study\-specific procedures, sampling and analyses.
•\- Participant must be 18 years or more at the time of signing the informed consent. All genders are permitted.
•\- Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
•\- Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
•\- Documented radiologic progression on first\- or second\-line treatment with osimertinib as the most recent anti\-cancer therapy.
•\- Mandatory provision of FFPE tumour tissue.
•\- MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
•\- Measurable disease as defined by RECIST 1\.1\.
•\- Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
•\- ECOG performance status of 0 or 1\.

•\- Predominant squamous NSCLC, and small cell lung cancer.
•\- Prior or current treatment with a third\-generation EGFR\-TKI other than Osimertinib.
•\- Prior or current treatment with savolitinib or another MET inhibitors.
•\- Spinal cord compression or brain metastases, unless asymptomatic and are stable.
•\- History or active leptomeningeal carcinomatosis.
•\- Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 with the exception of alopecia, haemoglobin 9\.0 g/dL or more, and Grade 2 prior platinum\-therapy related neuropathy.
•\- Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals..
•\- History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement..
•\- Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease..
•\- Receipt of live attenuated vaccine (including against COVID\-19\) within 30 days prior to the first dose of study intervention..